Restore Interbody Fusion System REC-08MP10

GUDID B07511000508MP100

Medium Lordotic Cervical Cage 8mm(H) x 14mm(W) x 12mm(D)

Republic Spine, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: B07511000508MP100
• NIH Device Record Key: cdb3611b-10a7-46c5-a891-c3aedd211f48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restore Interbody Fusion System
• Version Model Number: 110005-08MP10
• Catalog Number: REC-08MP10
• Company DUNS: 061891717
• Company Name: Republic Spine, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com

Device Dimensions

• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 8 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 8 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 8 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 8 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 8 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 8 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 8 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 8 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 8 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 8 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B07511000508MP100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190889

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B07511000508MP100]

Moist Heat or Steam Sterilization

[B07511000508MP100]

Moist Heat or Steam Sterilization

[B07511000508MP100]

Moist Heat or Steam Sterilization

[B07511000508MP100]

Moist Heat or Steam Sterilization

[B07511000508MP100]

Moist Heat or Steam Sterilization

[B07511000508MP100]

Moist Heat or Steam Sterilization

[B07511000508MP100]

Moist Heat or Steam Sterilization

[B07511000508MP100]

Moist Heat or Steam Sterilization

[B07511000508MP100]

Moist Heat or Steam Sterilization

[B07511000508MP100]

Moist Heat or Steam Sterilization

[B07511000508MP100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-30
• Device Publish Date: 2025-09-22

On-Brand Devices [Restore Interbody Fusion System]

• B07511002228S1106P0: Small Lordotic TLIF Cage - PEEK 28mm(L) x 9mm(W) x 11mm(H) x 6*(A)
• B07511000508MP100: Medium Lordotic Cervical Cage 8mm(H) x 14mm(W) x 12mm(D)